Short-term Spinal Stimulation Effects in Cerebral Palsy
Acute Effects of Transcutaneous Spinal Stimulation on Spasticity and Gait in Cerebral Palsy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Children with cerebral palsy (CP) have altered neuromuscular control that impacts gait and participation in daily activities. This research will characterize the acute effects of transcutaneous spinal stimulation (tSCS) on spasticity and gait for individuals with CP using a combined approach of quantitative biomechanical assessment and clinician assessment. Previous research has shown decreases in spasticity after walking with tSCS, but it is unclear whether these changes are due to physical activity or neuromodulation. This research will provide a foundation to characterize changes in spasticity after an acute session of tSCS for individuals with CP.
This research will use the SpineX Spinal Cord Innovation in Pediatrics (SCiP) system. The SCIP system allows for tSCS intensity (mA) at two electrodes to be independently adjusted in 1 mA increments. Other stimulation parameters such as pulse frequency (30 Hz), overlap frequency (10 kHz), pulse width (1 ms), and waveform (biphasic) are constant on the SCiP device. To target sensorimotor function of lower-extremity muscle groups within the spinal cord, the two electrodes are positioned over the spinous process at T11 and L1 with grounding electrodes placed on the pelvis. The tSCS intensity will be set to each individual's maximum tolerable stimulation intensity.
This study will recruit 20 individuals with CP to attend two in-lab visits. One visit will include treadmill walking with tSCS and the other will include treadmill walking without tSCS. The visit order will be pseudo-randomized and balanced across participants. Participants will be consented at the initial visit and will also conduct 3 trials of the 10-Meter Walk Test to evaluate self-selected walking speed. The average speed from these trials will be used to set treadmill speed. At the beginning of each visit, participants will complete a physical exam to characterize range of motion and spasticity via the Modified Tardieu Scale. Participants will complete a 5-minute treadmill familiarization at their self-selected speed to ensure it is comfortable. The tSCS intensity will gradually increase during treadmill familiarization until participants report discomfort. The tSCS intensity will be set at 1 mA below the level of discomfort if the visit calls for tSCS. During the treadmill walking, participants will walk at their self-selected walking speed for 10 - 20 minutes with either (1) no stimulation or (2) tSCS at their maximum tolerable stimulation intensity.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Katherine Steele, PhD
- Número de teléfono: 206-685-2390
- Correo electrónico: kmsteele@uw.edu
Copia de seguridad de contactos de estudio
- Nombre: Katie Landwehr, MS
- Número de teléfono: 206-543-0116
- Correo electrónico: klandweh@uw.edu
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98195
- Reclutamiento
- University of Washington
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Contacto:
- Katie Landwehr, MS
- Número de teléfono: 206-543-0116
- Correo electrónico: klandweh@uw.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Individuals who:
- have a diagnosis of spastic cerebral palsy or high likelihood of CP diagnosis
- are 4-65 years of age
- have spasticity in lower-extremity muscles
- are at a functional Gross Motor Function Classification System (GMFCS) Level I-III
- can walk for at least 10 minutes with/without support
- can understand and follow simple directions
- have a stable medical condition, as reported by the caregiver/parent
Exclusion Criteria:
Individuals who:
- who have had lower-extremity surgery or injury in the prior 12 months
- have had botulinum toxin injections in the prior 3 months
- have had selective dorsal rhizotomy (SDR) in the past
- have uncontrolled seizures
- have significant cardiovascular or musculoskeletal disease that would prevent full participation
- are dependent on ventilation support
- have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump)
- have established osteoporosis and taking medication for osteoporosis treatment.
- have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- have active cancer
- have received stem cell injections into the spinal cord
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Spinal Stimulation First (AB Arm)
Participants randomized into this arm will complete two visits.
The first visit will use spinal stimulation while walking on a treadmill, and the second visit will be treadmill walking without stimulation.
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A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).
Otros nombres:
Participant will walk on a treadmill.
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Experimental: No Spinal Stimulation First (BA Arm)
Participants randomized into this arm will complete two visits.
The first visit will involve walking on a treadmill without stimulation, while the second visit will be treadmill walking with stimulation.
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A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).
Otros nombres:
Participant will walk on a treadmill.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Modified Tardieu Scale of Spasticity
Periodo de tiempo: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
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Change in quality of muscle reaction of the gastrocnemius assessed by the score on the Tardieu assessment.
Lower score indicates less spasticity.
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End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Step Length
Periodo de tiempo: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
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From quantitative gait analysis step length is quantified as the average during the final minute of walking using gait analysis and markers on the foot.
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End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
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Gait Deviation Index (GDI)
Periodo de tiempo: Last 5 minutes of treadmill walking during visit relative to baseline at start of walking.
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A multivariate metric derived from quantitative gait analysis that quantifies how much a gait cycle deviates from normative data.
Average GDI calculated at the last 5 minutes of walking.
Higher GDI indicates more normative walking.
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Last 5 minutes of treadmill walking during visit relative to baseline at start of walking.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Katherine Steele, PHD, University of Washington
- Investigador principal: Heather Feldner, PhD, University of Washington
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00014877-A
- R21HD121135 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
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